重复 JAMA Neurol:高龄、亚洲人、严重卒中更能够从低剂量阿替普酶中获益(ENCHANTED研究)?

2017-12-06 杨中华 脑血管病及重症文献导读

在日本,允许采用低剂量阿替普酶治疗发病3h内的急性缺血性卒中,这是基于单臂(single-arm)研究(日本阿替普酶临床试验)的结果,该研究显示与其他人群采用标准剂量阿替普酶相比,日本人采用低剂量(0.6mg/kg;最大60mg)阿替普酶是安全和有效的。但是,除了日本以外标准剂量阿替普酶静脉溶栓仍然占绝对的主导地位。但是在亚洲国家,一些医生愿意选择低剂量阿替普酶,因为花费少,能够降低出血风险。

在日本,允许采用低剂量阿替普酶治疗发病3h内的急性缺血性卒中,这是基于单臂(single-arm)研究(日本阿替普酶临床试验)的结果,该研究显示与其他人群采用标准剂量阿替普酶相比,日本人采用低剂量(0.6mg/kg;最大60mg)阿替普酶是安全和有效的。但是,除了日本以外标准剂量阿替普酶静脉溶栓仍然占绝对的主导地位。但是在亚洲国家,一些医生愿意选择低剂量阿替普酶,因为花费少,能够降低出血风险。鉴于尚缺乏随机对照试验的证据,亚洲人群阿替普酶的最佳剂量仍然不清楚。

老年人和病情严重者都能从静脉溶栓中获益,但是这些患者发生sICH的风险更高。因此,这些患者可能能从低剂量阿替普酶中获益,并且降低sICH风险。

最近发表的ENCHANTED研究比较了低剂量阿替普酶和标准剂量阿替普酶的疗效,结果没有达到预先设定的非劣性界值。但是,按照mRS的顺序分析(ordinal analysis),ENCHANTED试验确实发现低剂量阿替普酶不次于标准剂量阿替普酶,并且严重sICH更低。因此,我们推测低剂量阿替普酶可能适用于某些特定的患者。

2017年11月来自澳大利亚的XiaWang等在JAMA Neurology上发表了他们的ENCHANTED研究二次分析结果,以探讨低剂量阿替普酶是否对老龄、亚洲人、严重卒中更加有效(vs 标准剂量)。

ENCHANTED为国际多中心、随机对照、开放标签、盲法终点的临床试验,验证了低剂量和标准剂量阿替普酶对急性缺血性卒中的疗效。本文为ENCHANTED的二次分析。

共3297例患者纳入本分析。他们发现,不同年龄、种族或严重程度的患者采用低剂量和标准剂量的治疗疗效(不良预后包括死亡或残疾)没有差异。同样,对于亚洲和非亚洲人群采用低剂量和标准剂量阿替普酶的疗效(功能预后,ordinal shift of the mRS)没有差异(P = 0.32 for interaction)。低剂量阿替普酶能够降低sICH,尽管不同年龄、种族或严重程度sICH发生率没有显著性差异。

最终作者认为ENCHANTED试验的二次分析发现在关键亚组中低剂量阿替普酶的疗效(死亡或残疾)并没有明显优于标准剂量阿替普酶。需要进一步研究哪一些患者将从低剂量阿替普酶治疗中获益。

原始出处:

Wang X1,2, Robinson TG3, Lee TH,et al.Low-Dose vs Standard-Dose Alteplase for Patients With Acute Ischemic Stroke: Secondary Analysis of the ENCHANTED Randomized Clinical Trial.JAMA Neurol.2017 Nov 1;74(11):1328-1335. doi: 10.1001/jamaneurol.2017.2286.

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    2018-11-22 aliceclz
  2. [GetPortalCommentsPageByObjectIdResponse(id=1702938, encodeId=811c1e0293803, content=<a href='/topic/show?id=72351e25437' target=_blank style='color:#2F92EE;'>#TED#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17254, encryptionId=72351e25437, topicName=TED)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=76e230462388, createdName=aliceclz, createdTime=Thu Nov 22 07:36:00 CST 2018, time=2018-11-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2000212, encodeId=657f200021214, content=<a href='/topic/show?id=d5df12695e6' target=_blank style='color:#2F92EE;'>#Neurol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12695, encryptionId=d5df12695e6, topicName=Neurol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8217292, createdName=yinhl1978, createdTime=Thu Aug 02 08:36:00 CST 2018, time=2018-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1416062, encodeId=5f5c141606267, content=<a href='/topic/show?id=99fb1028231b' target=_blank style='color:#2F92EE;'>#高龄#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=102823, encryptionId=99fb1028231b, topicName=高龄)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=307c3130149, createdName=xlysu, createdTime=Fri Dec 08 08:36:00 CST 2017, time=2017-12-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1480473, encodeId=d2c914804e39d, content=<a href='/topic/show?id=647d2615939' target=_blank style='color:#2F92EE;'>#低剂量#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=26159, encryptionId=647d2615939, topicName=低剂量)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=97b17641126, createdName=ms1292405679162969, createdTime=Fri Dec 08 08:36:00 CST 2017, time=2017-12-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=267320, encodeId=0d8226e32003, content=很多这些出血风险的药物在亚洲人群都应该使用低剂量, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c4a5105539, createdName=lovetcm, createdTime=Wed Dec 06 20:46:52 CST 2017, time=2017-12-06, status=1, ipAttribution=)]
    2018-08-02 yinhl1978
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    2017-12-08 xlysu
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    2017-12-06 lovetcm

    很多这些出血风险的药物在亚洲人群都应该使用低剂量

    0

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JAMA Neurol:高龄、亚洲人、严重卒中更能够从低剂量阿替普酶中获益?

在日本,允许采用低剂量阿替普酶治疗发病3h内的急性缺血性卒中,这是基于单臂(single-arm)研究(日本阿替普酶临床试验)的结果,该研究显示与其他人群采用标准剂量阿替普酶相比,日本人采用低剂量(0.6mg/kg;最大60mg)阿替普酶是安全和有效的。但是,除了日本以外标准剂量阿替普酶静脉溶栓仍然占绝对的主导地位。但是在亚洲国家,一些医生愿意选择低剂量阿替普酶,因为花费少,能够降低出血风险。鉴于